Eli Lilly applies for emergency use of antibody drug for COVID-19

By Manas Mishra and Carl O'Donnell

(Reuters) - Eli Lilly and Co <LLY.N> on Wednesday said it applied for U.S. emergency use authorization (EUA) for its experimental COVID-19 antibody treatment and plans to pursue a similar approval for a dual antibody therapy next month after it produced promising data.

The drugmaker said its two-antibody cocktail helped reduce viral levels more than the single antibody treatment had in a prior study. The lower viral load was potentially tied to a reduction in COVID-19 symptoms, the company said.

"We believe that Lilly's data provides some real evidence that the combo mAb (monoclonal antibody) approach may provide meaningful clinical benefits," Baird analyst Brian Skorney said.

Shares of the Indianapolis drugmaker were up more than 3%.

Data in September showed that Lilly's single antibody therapy, LY-CoV555, which is being developed with Canadian biotech AbCellera, helped cut hospitalization and emergency room visits for COVID-19 patients.

Based on that data, Lilly applied for an EUA with the U.S. Food and Drug Administration and said it expects about one million doses of the biotech drug to be available by the end of the year.

Several drugmakers are testing antibody treatments for COVID-19 as a means of helping patients' immune systems fight the virus. None of those drugs have been authorized for emergency use in the United States.

An experimental dual-antibody cocktail developed by Regeneron Pharmaceuticals Inc <REGN.O> was among the medicines given to U.S. President Donald Trump to treat his COVID-19. The company supplied the drug through a compassionate use program.

Lilly chose not to distribute its experimental drug via a compassionate use program, preferring to recruit patients in need for its clinical trials due to the urgency to generate data showing that it works, Chief Executive David Ricks said on a conference call.

In the study involving 268 patients with mild-to-moderate COVID-19, nearly 1% of those who received the Lilly dual-antibody therapy required hospitalization. That compared with 5.8% who got a placebo, suggesting a clinically meaningful response.

The combination therapy also met the trial's main goal of significantly reducing the amount of virus present 11 days after treatment, compared with a placebo, Lilly said. The treatment also reduced viral levels at day three and day seven.

Lilly expects to supply 50,000 doses of the combination therapy in the fourth quarter.

(Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta and Bill Berkrot)